title: Oral intradialytic nutritional supplement use and mortality in hemodialysis patients.
abstract: BACKGROUND
  Hemodialysis patients have high mortality rates, potentially reflecting underlying comorbid conditions and ongoing catabolism. Intradialytic oral nutritional supplements may reduce this risk.
  
  
  METHODS
  Retrospective propensity-matched cohort.
  
  
  METHODS
  Maintenance hemodialysis patients treated at Dialysis Clinic Inc facilities who were initiated on a nutritional supplement protocol in September to October 2010 were matched using a propensity score to patients at facilities at which the protocol was not used.
  
  
  METHODS
  Prescription of the protocol, whereby hemodialysis patients with serum albumin levels ≤3.5g/dL would initiate oral protein supplementation during the dialysis procedure. Sensitivity analyses matched on actual supplement intake during the first 3 study months. Covariates included patient and facility characteristics, which were used to develop the propensity scores and adjust multivariable models.
  
  
  RESULTS
  All-cause mortality, ascertained though March 2012.
  
  
  RESULTS
  Of 6,453 eligible patients in 101 eligible hemodialysis facilities, the protocol was prescribed to 2,700, and 1,278 of these were propensity matched to controls. Mean age was 61 ± 15 (SD) years and median dialysis vintage was 34 months. There were 258 deaths among protocol assignees versus 310 among matched controls during a mean follow-up of 14 months. In matched analyses, protocol prescription was associated with a 29% reduction in the hazard of all-cause mortality (HR, 0.71; 95% CI, 0.58-0.86); adjustment had minimal impact on models. In time-dependent models incorporating change in albumin level, protocol status remained significant but was attenuated in models incorporating a 30-day lag. Similar results were seen in sensitivity analyses of 439 patients receiving supplements who were propensity-matched to controls, with 116 deaths among supplement users versus 140 among controls (HR, 0.79; 95% CI, 0.60-1.05), achieving statistical significance in adjusted models.
  
  
  CONCLUSIONS
  Observational design, potential residual confounding.
  
  
  CONCLUSIONS
  Prescription of an oral nutritional supplement protocol and use of oral protein nutritional supplements during hemodialysis are associated with reduced mortality among in-center maintenance hemodialysis patients, an effect likely not mediated by change in serum albumin levels.
authors.affiliation: William B. Schwartz Division of Nephrology, Tufts Medical Center, Boston, MA. Electronic address: dweiner@tuftsmedicalcenter.org.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Weiner
authors.affiliation: Biostatistics Research Center, Boston, MA.
authors.forename: Hocine
authors.initials: H
authors.lastname: Tighiouart
authors.affiliation: Dialysis Clinic Inc, Winnetka, IL.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Ladik
authors.affiliation: William B. Schwartz Division of Nephrology, Tufts Medical Center, Boston, MA.
authors.forename: Klemens B
authors.initials: KB
authors.lastname: Meyer
authors.affiliation: Dialysis Clinic Inc, Albuquerque, NM.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Zager
authors.affiliation: Dialysis Clinic Inc, Nashville, TN.
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Johnson
mesh_terms: D000284:Administration, Oral; D000368:Aged; D015331:Cohort Studies; D004044:Dietary Proteins / Q000008:administration & dosage*; D019587:Dietary Supplements; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality*; D012189:Retrospective Studies
chemical_list: D004044:Dietary Proteins
keywords: Hemodialysis; catabolism; mortality; nutrition; nutritional supplement; oral nutritional supplement (ONS); serum albumin